Product code DOE

Device name: Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Medical specialty: Clinical Toxicology
Device class: 2
Regulation number: 862.3640
Review panel: TX
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K010079	INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST	Alfa Scientific Designs, Inc.	2001-05-29
K010080	INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST	Alfa Scientific Designs, Inc.	2001-05-29
K011011	LIVESURE MORPHINE SCREEN TEST	Pan Probe Biotech, Inc.	2001-04-13
K002418	BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D	Branan Medical Corporation	2000-11-22
K951319	ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION	Roche Diagnostic Systems, Inc.	1995-06-01
K935055	ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)	Roche Diagnostic Systems, Inc.	1994-08-09
K933572	URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1994-04-06
K881102	MICROMEDIC MORPHINE RIA KIT	Icn Micromedic Systems	1988-06-24
K863913	THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT	Diagnostic Products Corp.	1987-03-19
K864168	MORPHINE ROCHE (R) EIA TEST	Roche Diagnostic Systems, Inc.	1987-03-16
K830460	ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE	Hoffmann-La Roche, Inc.	1983-03-24
K830462	ABUSCREEN RADIOUMMUNOASSAY--URINE	Hoffmann-La Roche, Inc.	1983-03-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10796918001136	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET1000, MOR2000, THC, X	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001129	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET500, MOR300, THC, XTC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001112	INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET, MOR300, THC, XTC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001105	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR, THC, XTC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001099	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET1000, MOR2000, T	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001082	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET1000, MOR2000, T	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001075	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET1000, MOR300, PCP, TH	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001068	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR/OPI300, THC, XT	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001051	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR300, PCP, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001044	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR2000, PCP, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001037	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918001020	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-23
10796918000993	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR300, PCP, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918001013	INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918001006	INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000696	INSTANT-VIEW Multi-Drugs of Abuse Urine Test MET500, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000986	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, MET1000, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000979	INSTANT-VIEW Multi-Drugs of Abuse Urine Test BAR, BZD, MET500, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000955	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000917	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BUP, MET, MOR300, MTD	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000900	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MET, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000870	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000863	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000849	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET500, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000825	INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MOR2000, MTD	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000818	INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000795	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000788	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR/OPI300, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000764	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR2000, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22
10796918000757	INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR, THC	ALFA SCIENTIFIC DESIGNS, INC.	2016-09-22

Product code DOE

Related 510(k) Records#

Related GUDID Devices#